Promethazine Hydrochloride NDC 72162-2071

NDC codes

FDA NDC Directory

Product NDC (as listed)72162-2071Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72162-2071Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
72162-2071-2	72162207102	473 mL in 1 BOTTLE (72162-2071-2)Marketed from Aug 15, 2023

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Promethazine Hydrochloride
Generic name (nonproprietary): promethazine hydrochloride
Active ingredients: Promethazine hydrochloride — 6.25 mg/5mL
Dosage form: Solution
Route: Oral
Labeler: Bryant Ranch Prepack
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213890
Marketing start: Jul 12, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Phenothiazines (Chemical structure)
Identifiers: Product ID 72162-2071_f04e3aa5-37d8-4ba8-919f-9c61255b5bc4SPL ID f04e3aa5-37d8-4ba8-919f-9c61255b5bc4SPL set ID 07914b6e-c40f-44be-a1db-8724c70f99b6RxCUI 992432UNII R61ZEH7I1I
Pharmacologic class: Phenothiazine

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N472162207102 followed by a unit qualifier and the quantity

Package 72162-2071-02. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Aug 15, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Promethazine is useful for: Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of post-operativ…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 213890

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 213890
Product	Strength	Form · route	Labeler	Product NDC
Promethazine Hydrochloride	Promethazine hydrochloride 6.25 mg/5mL	SolutionOral	QUAGEN PHARMACEUTICALS LLC	70752-138